N/A
Completed N=42
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
Source: ClinicalTrials.gov NCT01790828 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants by Family History of Factor VIII Inhibitor — 0; 100.0 percentage of participants
Summary
This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants by Family History of Factor VIII Inhibitor |
0; 100.0 | — |
| SECONDARY Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants) |
1.40 | — |
| SECONDARY Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age |
1.00 | — |
| SECONDARY Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age |
1.50 | — |
| SECONDARY Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants) |
5; 2; 0; 0 | — |
| SECONDARY Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age |
1; 0; 0; 0 | — |
| SECONDARY Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age |
4; 2; 0; 0 | — |
| SECONDARY Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy |
— | — |
| SECONDARY Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants) |
1997.00 | — |
| SECONDARY Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age |
725.00 | — |
| SECONDARY Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age |
2315.00 | — |
| SECONDARY Percentage of Participants Experiencing Hemorrhages During Prophylaxis |
0; 0; 0 | — |
| SECONDARY Annualized Bleeding Rates During Prophylaxis |
— | — |
| SECONDARY Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha |
— | — |
| SECONDARY Average Infusion Dose During Prophylaxis (All Participants) |
1926.70 | — |
| SECONDARY Average Infusion Dose During Prophylaxis in Participants <18 Years of Age |
1243.75 | — |
| SECONDARY Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age |
2000.16 | — |
| SECONDARY Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants) |
66371.00 | — |
| SECONDARY Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age |
2900.00 | — |
| SECONDARY Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age |
70104.59 | — |
Eligibility Criteria
Inclusion Criteria
- Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
- Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha.
Exclusion Criteria
- Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product.
- Patients with a known history of hypersensitivity to hamster protein.
- Patients participating in an interventional trial of any investigational drug or device.
Data sourced from ClinicalTrials.gov (NCT01790828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.